A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Phase 4

Not yet recruiting

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Drug: Vedolizumab IV; Drug: Vedolizumab SC

• Registration Number: NCT06581328
• Lead Sponsor: Takeda

Brief Summary

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).

Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.

During the study, participants will visit their study clinic several times.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Study Start: 2025-02-12
• Primary Completion: 2027-10-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC Participants: Vedolizumab	Vedolizumab IV	Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
UC Participants: Vedolizumab	Vedolizumab SC	Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
CD Participants: Vedolizumab	Vedolizumab IV	Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
CD Participants: Vedolizumab	Vedolizumab SC	Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.

Primary Outcome Measures

Name	Time	Method
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14	At Week 14	PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
Percentage of UC Participants With PRO-2 Remission at Week 14	At Week 14	PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.

Secondary Outcome Measures

Name	Time	Method
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52	At Weeks 6 and 52	PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52	At Weeks 6, 14, and 52	CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point(s) or absolute rectal bleeding sub-score of \<=1 point or absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit.
Percentage of CD Participants With Endoscopic Response at Week 52	At Week 52	Endoscopic response is defined as \>=50% reduction from baseline (or for participants with isolated ileal disease, SES-CD \<= 4 or at least a 2-point reduction from baseline) in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Percentage of CD Participants Achieving Endoscopic Remission at Week 52	At Week 52	Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52	At Week 52	Improvement of endoscopic appearance of the mucosa is defined as Mayo endoscopic sub-score = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]).
Percentage of UC Participants With Endoscopic Remission at Week 52	At Week 52	Endoscopic remission is defined as a centrally read complete Mayo endoscopy subscore of 0.
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52	At Weeks 6, 14, and 52	Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1.
Percentage of CD and UC Participants With Clinical Remission at Week 52	At Week 52	Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52	Baseline, Weeks 6, 14, and 52	Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52	Baseline, Weeks 6, 14, and 52	Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Number of CD and UC Participants With Serious Infections	Up to end of study (up to 72 weeks)	Number of CD and UC participants with serious infections will be reported.